Label: NITROFURANTOIN- nitrofurantoin macrocrystals capsule
- NDC Code(s): 71335-1135-1, 71335-1135-2, 71335-1135-3, 71335-1135-4, view more
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0115-1645
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 8, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONTo reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals and other antibacterial drugs, nitrofurantoin macrocrystals should be used only ...
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DESCRIPTIONNitrofurantoin Capsules, USP (Macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin Capsules, USP (Macrocrystals) are an ...
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CLINICAL PHARMACOLOGYNitrofurantoin macrocrystals are a larger crystal form of nitrofurantoin. The absorption of nitrofurantoin macrocrystals is slower and its excretion somewhat less when compared to nitrofurantoin ...
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MICROBIOLOGYNitrofurantoin is a nitrofuran antimicrobial agent with activity against certain Gram-positive and Gram-negative bacteria. Mechanism of Action - The mechanism of the antimicrobial action of ...
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INDICATIONS AND USAGENitrofurantoin Capsules USP (Macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci ...
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CONTRAINDICATIONSAnuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of ...
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WARNINGSPulmonary Reactions - ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, NITROFURANTOIN MACROCRYSTALS SHOULD BE ...
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PRECAUTIONSInformation for Patients - Patients should be advised to take nitrofurantoin macrocrystals with food to further enhance tolerance and improve drug absorption. Patients should be instructed to ...
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ADVERSE REACTIONSRespiratory - CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR. CHRONIC PULMONARY REACTIONS OCCUR GENERALLY IN PATIENTS WHO HAVE RECEIVED CONTINUOUS TREATMENT FOR SIX ...
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OVERDOSAGEOccasional incidents of acute overdosage of nitrofurantoin macrocrystals have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific ...
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DOSAGE AND ADMINISTRATIONNitrofurantoin capsules (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance. Adults - 50 to 100 mg four times a day - the lower dosage level is ...
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HOW SUPPLIEDNitrofurantoin Capsules USP (Macrocrystals) are available as pink opaque capsules, imprinted with z, “Zenith 100 mg” on the cap and “2131”, underlined with a triple bar, on the body, in black ...
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SPL UNCLASSIFIED SECTIONManufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit - Ahmedabad 382213, INDIA - Distributed by: Amneal Pharmaceuticals LLC - Bridgewater, NJ 08807 - Rev. 06-2020-00
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PRINCIPAL DISPLAY PANELNitrofurantoin Macro. 100mg Capsule
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INGREDIENTS AND APPEARANCEProduct Information